Medical Device Manufacturer · US , Marietta , GA

Coloplast Corp.

54 submissions · 47 cleared · Since 1985
54
Total
47
Cleared
0
Denied

Coloplast Corp. — FDA 510(k) Submissions

Coloplast Corp. has submitted 54 FDA 510(k) premarket notifications since 1985, of which 47 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stent, Ureteral, Catheter, Straight, Dressing, Wound, Drug, Catheter, Urethral, Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed . Use the specialty filter in the sidebar to narrow results.

54 devices
1–25 of 54
Heylo? System
K252140 · EXB Collector, Ostomy · Gastroenterology & Urology
Oct 2025 90d
Luja Coud?
K251116 · EZD Catheter, Straight · Gastroenterology & Urology
Jun 2025 77d
Luja Set
K250270 · EZD Catheter, Straight · Gastroenterology & Urology
Apr 2025 77d
SureCath Set
K242049 · EZD Catheter, Straight · Gastroenterology & Urology
Nov 2024 137d
Luja Coude
K241210 · EZD Catheter, Straight · Gastroenterology & Urology
Nov 2024 205d
Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)
K242173 · FED Endoscopic Access... · Gastroenterology & Urology
Nov 2024 111d
Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)
K242473 · PAH Mesh, Surgical,... · Gastroenterology & Urology
Oct 2024 59d
Folysil Silicone Catheter
K233411 · EZL Catheter, Retention Type,... · Gastroenterology & Urology
Apr 2024 192d
Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)
K231953 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Mar 2024 266d
Luja Coude (20108 Male CH18 - large packaging)
K233101 · EZD Catheter, Straight · Gastroenterology & Urology
Oct 2023 30d
ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits
K213185 · FAD Stent, Ureteral · Gastroenterology & Urology
Jun 2022 252d
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
K211911 · LJE Catheter, Nephrostomy · Gastroenterology & Urology
Mar 2022 262d
NovoFlow Reinforced Ureteral Stent
K213186 · FAD Stent, Ureteral · Gastroenterology & Urology
Feb 2022 140d
Vortek Single Loop Ureteral Stent
K201436 · FAD Stent, Ureteral · Gastroenterology & Urology
Feb 2021 269d
In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
K201165 · LJE Catheter, Nephrostomy · Gastroenterology & Urology
Dec 2020 230d
In-Ka Ureteral Balloon Dilatation Catheter
K201007 · EZN Dilator, Catheter, Ureteral · Gastroenterology & Urology
Jun 2020 55d
SabreLine and SabreGuard Laser Fibers
K182831 · GEX Powered Laser Surgical... · General & Plastic Surgery
Dec 2018 62d
ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
K180469 · FAD Stent, Ureteral · Gastroenterology & Urology
Nov 2018 258d
Ureteric Catheters
K182122 · EYB Catheter, Ureteral,... · Gastroenterology & Urology
Oct 2018 59d
VORTEK URETERAL DOUBLE LOOP STENT
K180057 · FAD Stent, Ureteral · Gastroenterology & Urology
Mar 2018 60d
Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
K171043 · EYB Catheter, Ureteral,... · Gastroenterology & Urology
Dec 2017 258d
VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS
K170362 · FAD Stent, Ureteral · Gastroenterology & Urology
Nov 2017 282d
BIOSOFT DUO DOUBLE LOOP URETERAL STENTS
K170422 · FAD Stent, Ureteral · Gastroenterology & Urology
Nov 2017 262d
Ureteral Dilators and Percutaneous Nephrostomy Dilators
K170531 · EZN Dilator, Catheter, Ureteral · Gastroenterology & Urology
Aug 2017 176d
SpeediCath Flex Coude
K161672 · GBM Catheter, Urethral · Gastroenterology & Urology
Sep 2016 112d
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